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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lamp, infrared, therapeutic heating
Regulation Description Infrared lamp.
Product CodeILY
Regulation Number 890.5500
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
ALMA LASERS LTD.
  SUBSTANTIALLY EQUIVALENT 1
ALTUS MEDICA
  SUBSTANTIALLY EQUIVALENT 1
APOLLO CORP.
  SUBSTANTIALLY EQUIVALENT 1
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BIOLASE TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
CELL GEN
  SUBSTANTIALLY EQUIVALENT 1
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 1
CHUNG CHENG ELECTRIC HEATING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CLARIMEDEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
COTTONWOOD VESSEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CURAE'LASE INC.
  SUBSTANTIALLY EQUIVALENT 2
CUTERA, INC.
  SUBSTANTIALLY EQUIVALENT 1
CYNOSURE, INC.
  SUBSTANTIALLY EQUIVALENT 4
DIOMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DYNATRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 4
EL.EN. ELECTRONIC ENGINEERING SPA
  SUBSTANTIALLY EQUIVALENT 1
ELTECH, S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
HEALTHTEAM
  SUBSTANTIALLY EQUIVALENT 2
HELIO MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HILL LABORATORIES CO.
  SUBSTANTIALLY EQUIVALENT 2
HOME SKINOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 2
JEISYS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
LASER THERA, LLC
  SUBSTANTIALLY EQUIVALENT 2
LED INTELLECTUAL PROPERTIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
LED TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
LIFE WITHOUT PAIN, LLC
  SUBSTANTIALLY EQUIVALENT 1
LIGHTHOUSE TECHNICAL INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LITECURE, LLC
  SUBSTANTIALLY EQUIVALENT 3
LUTRONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LYNTON LASERS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL LASER SYSTEMS INC
  SUBSTANTIALLY EQUIVALENT 1
MEDX
  SUBSTANTIALLY EQUIVALENT 4
MERIDIAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
METTLER ELECTRONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
MICROLIGHT CORPORATION OF AMERICA
  SUBSTANTIALLY EQUIVALENT 2
NEW STAR LASERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
OMNILIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PALOMAR MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
PHAROS LIFE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PHOTO THERAPEUTICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
POWERMEDIC APS
  SUBSTANTIALLY EQUIVALENT 2
PREMIER DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRIME HERBS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QUANTUM
  SUBSTANTIALLY EQUIVALENT 2
RAINBOW COMMUNICATIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
RICH-MAR CORP.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOMETECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU MEDICAL APPLIANCE FACTORY
  SUBSTANTIALLY EQUIVALENT 1
THOR INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
UNITED INTEGRATED SERVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
WS FAR IR MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 1
Total Device Problems 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 1 0 1 0 0 1 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cutera Inc II Nov-09-2010
2 LED Technologies, LLC II Apr-28-2016
3 Pivotal Health Solutions II Mar-06-2015
4 Quasar Bio-Tech, Inc. dba Silver Bay LLC II Dec-12-2012
5 Suarez Corporation Industries II Aug-07-2009

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